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The mean cost per participant for COPD-related healthcare interventions for one year following the index date (first pharmacy claim for fluticasone propionate/salmeterol 250 µg/50 µg [FSC] or tiotropium bromide [TIO]) was calculated. Total medical costs included inpatient, emergency department, and outpatient costs associated with the treatment of COPD. Total pharmacy costs included costs of all COPD-related medications, and total healthcare costs included all medical and pharmacy costs that were related to COPD treatment. These costs were unadjusted and reflect the actual costs.

Mean Number of COPD Exacerbations [ Time Frame: 1 year ]

Moderate COPD exacerbations were defined as the occurrence of a COPD-related emergency department (ED) visit or a COPD-related office visit that is closely followed by a prescription claim for oral steroids or antibiotics. Severe exacerbations were defined as the occurrence of a COPD-related hospital admission.

The adjusted costs for medical services, pharmacy, and the total costs for COPD-related health care for patients in the fluticasone propionate/salmeterol (FSC) and tiotropium bromide (TIO) treatment groups

Risk of COPD exacerbation [ Time Frame: 12 months ]

The relative risks of exacerbations will be assessed using Cox proportional hazards models. Exacerbations will reported by severity - moderate exacerbation (claim for a COPD-related office visit or emergency department[ED] visit followed by a prescription claim for antibiotics or oral corticosteriods), severe exacerbation (claim for a COPD-related hospitalization) and any exacerbation

A measure of resource utilization. The number and percentage of patient records with one or more encounters for inpatient services, emergency department (ED) visits, office visits, other outpatient/ancillary services, and pharmacy

Chronic obstructive pulmonary disease (COPD) is characterized by chronic airflow limitation caused by inflammation-mediated damage to lung tissue. Although damage to lung tissue in COPD appears to be irreversible, evidence suggests that the course of COPD can be altered through measures such as smoking cessation, pulmonary rehabilitation, and the use of pharmacotherapy for bronchodilation. A primary goal of maintenance pharmacotherapy is to reduce the incidence of acute exacerbations and the associated hospitalizations and emergency department (ED) visits. Bronchodilation in COPD maintenance therapy can be accomplished with the long-acting anticholinergic tiotropium (TIO), long acting beta-agonists (e.g. formoterol, salmeterol), methylxanthines (e.g. theophylline), or combination therapy with a long-acting beta-agonist and an inhaled corticosteroid (e.g. fluticasone propionate/salmeterol [FSC]).

The objective of this study is to compare the benefits of combination long-acting beta-agonist/inhaled corticosteroid therapy to long-acting anticholinergic therapy. The study compares the risk of COPD exacerbations and COPD-related healthcare utilization and costs for commercially-insured patients age 40 and older who were prescribed FSC to those prescribed TIO. The null hypothesis is that no difference exists between the costs and outcomes of COPD patients treated with TIO and those treated with FSC. The test hypothesis is that patients treated with either TIO or FSC will incur lower costs and use fewer healthcare resources for the management of COPD.

The source of data for this study was the Ingenix Impact database (formerly the Integrated Healthcare Information Services [IHCIS] database). This is an administrative claims database that includes patient-level data on enrollment, facility, professional, and pharmacy services from approximately 50 million patients covered by more than 40 managed care health plans across the United States (US).

The study design is a retrospective cohort study.

Detailed Description

Not Provided

Study Type

Observational

Study Design

Observational Model: CohortTime Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patient records for commercially-insured patients with chronic obstructive pulmonary disease (COPD) aged 40 and older. For the risk-analysis population, patients were required to have at least 12 months of continuous enrollment prior to the index date and at least 3 months of continuous enrollment after the index date. A subgroup analysis was conducted for costs that included patients in the total population who also had at least 12 months of continuous coverage following the index date (the cost-analysis population).

Condition

Pulmonary Disease, Chronic Obstructive

Intervention

Drug: fluticasone propionate/salmeterol 250µg/50µg (FSC)

Patient records with evidence of COPD and prescription claims for FSC

Other Name: Advair®

Drug: tiotropium bromide (TIO)

Patient records with evidence of COPD and prescription claims for TIO

Other Name: Spriva®

Study Groups/Cohorts

COPD patients - risk analysis population

Patient-records from patients aged 40 and older with at least 2 medical claims with a diagnosis of COPD, at least on diagnosis in the 12 months prior to the index date and at least one diagnosis in the post-index date observation period, and at least one prescription claim for either FSC 250 µg/50µg or TIO. Patient records for the risk analysis population will be required to have continuous medical and pharmacy health plan enrollment for at least 12 months before and at least 3 months after the index date. The index date will be defined as the date of the first prescription claim for FSC or TIO (between January 1, 2004 and June 30, 2008).

Interventions:

Drug: fluticasone propionate/salmeterol 250µg/50µg (FSC)

Drug: tiotropium bromide (TIO)

COPD patients - cost analysis population

Patient-records from patients aged 40 and older with at least 2 medical claims with a diagnosis of COPD, at least on diagnosis in the 12 months prior to the index date and at least one diagnosis in the post-index date observation period, and at least one prescription claim for either FSC 250 µg/50µg or TIO. The cost analysis population is a subset of the risk analysis population. Patient records for the cost analysis population will be required to have continuous medical and pharmacy health plan enrollment for at least 12 months before and at least 12 months after the index date. The index date will be defined as the date of the first prescription claim for FSC or TIO (between January 1, 2004 and September 30, 2007).

Interventions:

Drug: fluticasone propionate/salmeterol 250µg/50µg (FSC)

Drug: tiotropium bromide (TIO)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.